Microalbuminuria, Cardiovascular Diseases, Renal Disease
Conditions
Brief summary
The Prevention of Renal and Vascular Endstage Disease Intervention Trial (PREVEND IT) was designed to determine whether intervention with the angiotensin-converting enzyme (ACE) inhibitor fosinopril and/or the hydroxymethylglutaryl coenzyme A reductase inhibitor pravastatin reduced cardiovascular and renal events in nonhypertensive, nonhypercholesterolemic subjects with microalbuminuria.
Detailed description
This study describes the rationale, design, and baseline characteristics of a trial to determine whether treatment with fosinopril 20 mg/day and/or pravastatin 40 mg/ day will prevent cardiovascular and renal disease in nonhypertensive (RR \<160/100 mm Hg and not using antihypertensive medication) and nonhypercholesterolemic (total cholesterol \<8.0 or \<5.0 mmol/L in case of previous myocardial infarction and not using lipid lowering medication) men and women with persistent microalbuminuria (urinary albumin excretion \>10 mg/L once in an early morning spot urine and 15 to 300 mg/24-hour at least once in two 24-hour urine collections). The Prevention of REnal and Vascular ENdstage Disease Intervention Trial is a single-center, double-blind, randomized, placebo-controlled trial with a 2 x 2 factorial design. The 864 randomized subjects will be monitored for a minimum of 4 years and a maximum of 5 years. The primary efficacy parameter is defined as the combined incidence of all-cause mortality or hospital admission for documented (1) nonfatal myocardial infarction, (2) myocardial ischemia, (3) heart failure, (4) peripheral vascular disease, (5) cerebrovascular accident and/or (6) end-stage renal disease.
Interventions
DRUGFosinopril
oral administration, capsules
DRUGPravastatin
oral administration, capsules
DRUGFosinopril Placebo
oral administration, capsules
DRUGPravastatin Placebo
oral administration, capsules
Sponsors
Dutch Kidney Foundation
Netherlands Heart Foundation
University Medical Center Groningen
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Persistent microalbuminuria (urinary albumin excretion \>10mg/L once in an early morning spot urine and 15 to 300 mg/24 hours at least once in two 24-hour urine samples) * No hypertension (RR \<160/100 mm Hg, no anti-hypertensive medication) * No hypercholesterolemia (total cholesterol \<8.0 or \<5.0 mmol/L in case of previous myocardial infarction and not using lipid-lowering medication)
Exclusion criteria
* Creatinine clearance \>60% of the normal age-adjusted value * Serum potassium \>5.5 mmol/L * History of chronic liver disease * Lactate dehydrogenase, aspartate-amino transferase or alanine-amino transferase \>3 times the upper limit of normal * Use of angiotensin-converting enzyme inhibitors or angiotensin II receptor antagonists * Use of insulin * Previously documented allergy or intolerance to study drugs * Pregnant or nursing women
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Combined incidence of all-cause mortality, MACE and/or end-stage renal disease | 4 years | Combined incidence of all-cause mortality or hospital admission for documented (1) non-fatal myocardial infarction, (2) myocardial ischemia, (3) heart failure, (4) peripheral vascular disease, (5) cerebrovascular accident and/or (6) end-stage renal disease |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of all-cause mortality | 4 years | Incidence of all-cause mortality |
| effect of treatment on microalbuminuria | 4 years | albumin excretion mg/24 h |
| effect of treatment on LDL cholesterol | 4 years | in mmol/L |
| effect of treatment on blood pressure | 4 years | in mmHg |
| Incidence of hospital admission | 4 years | Incidence of hospital admission for documented (1) non-fatal myocardial infarction, (2) myocardial ischemia, (3) heart failure, (4) peripheral vascular disease, (5) cerebrovascular accident and/or (6) end-stage renal disease |
Outcome results
None listed